The invention relates in an aspect to a method for manufacturing a hydroxyethyl starch derivatives.
Patients suffering from end-stage renal disease under chronic haemodialysis often show iron deficiency anaemia. This is based on the fact that the application of recombinant human erythropoietin in haemodialysis results in an enhanced iron requirement which cannot be satisfied by intestinal iron absorption. Therefore, iron supplementation is necessary to support an erythropoiesis initiated by erythropoietin therapy to counteract renal anaemia.
There exist several formulations for administering iron to patients. These formulations are usually complexes of iron ions with polymeric carbohydrates like dextran or organic compounds like sucrose or gluconate to form polynuclear complexes with metal ions.
In particular, dextran complexing iron has been used in the past to treat iron deficiency anaemia. However, such dextrans have comparatively many side effects and can show an anaphylactic effect, because anti-streptococci antibodies can react onto dextrans.
Ternes et al.: “Iron availability and complex stability of iron hydroxyethyl starch and iron dextran—a comparative in vitro study with liver cells and macrophages”, Nephrology Dialysis Transplantation 22 (2007), 2824-2830 described the use of hydroxyethyl starch as carrier for iron ions. However, no suited manufacturing method by which high amounts of hydroxyethyl starch can be produced in a reliable manner has been published so far.